K261112
- 510(k) number
- K261112
- Device name
- CastleLoc-P Anterior Cervical Plate System
- Applicant
- L&K BIOMED Co., Ltd. KR
- Product code
- KWQ — Appliance, Fixation, Spinal Intervertebral Body
- Decision date
- 2026-05-06
- Date received
- 2026-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K261112.pdf
Official FDA record: K261112
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.